A Phase 1/2, Open-label Study of Nivolumab Monotherapy or Nivolumab combined with Ipilimumab in Subjects with Advanced or Metastatic Solid Tumors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- Objective response rate (ORR) in all assigned subjects as determined by the investigators. ORR is defined as the number of subjects with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of assigned subjects
研究概览
简要总结
To investigate the safety and efficacy of Nivolumab as a single agent or in combination with Ipilimumab in 6 tumor types - triple-negative breast cancer (TNBC), gastric cancer (GC), pancreatic adenocarcinoma (PC), and small cell lung cancer (SCLC), Bladder Cancer (BC) and Ovarian Cancer (OC).
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Subjects with histologically confirmed locally advanced or metastatic disease of the following tumor types: Triple Negative Breast Cancer
- •Subjects with histologically confirmed locally advanced or metastatic disease of the following tumor types:Gastric Cancer
- •Subjects with histologically confirmed locally advanced or metastatic disease of the following tumor types:Pancreatic Cancer
- •Subjects with histologically confirmed locally advanced or metastatic disease of the following tumor types:Small Cell Lung Cancer
- •Subjects with histologically confirmed locally advanced or metastatic disease of the following tumor types:Ovarian Carcinoma
- •Subjects with histologically confirmed locally advanced or metastatic disease of the following tumor types:Bladder Cancer
- •Subjects must have measurable disease
- •ECOG of 0 or 1.
排除标准
- •Active brain metastases or leptomeningeal metastases
- •Subjects with active, known or suspected autoimmune disease
- •Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment
- •Prior therapy with experimental anti-tumor vaccines; any T cell costimulation or checkpoint pathways, such as anti-PD-1, anti-PD-L1, anti- PD-L2, anti-CD137, or anti-CTLA-4 antibody, including ipilimumab; or other medicines specifically targeting T cell is also prohibited
结局指标
主要结局
Objective response rate (ORR) in all assigned subjects as determined by the investigators. ORR is defined as the number of subjects with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of assigned subjects
Objective response rate (ORR) in all assigned subjects as determined by the investigators. ORR is defined as the number of subjects with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of assigned subjects
次要结局
- Rate of treatment-related adverse events (AEs) leading to drug discontinuations during the first 12 weeks of treatment
- Progression Free Survival (PFS)
- Overall Survival (OS)
研究者
GSM-CT
Scientific
Bristol Myers Squibb International Corporation